Founder: Myrl Jeffcoat
Website for Women's Implant Support: http://www.homestead.com/siliconecity
E-Mail:   myrl_jeffcoat@yahoo.com

March 6, 2000  

UP TO THE MINUTE STOCK QUOTES FOR ALL OF "OUR" MANUFACTURERS

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A MESSAGE FROM MARTI JACOBS
Thank you Marti for all your hard work in providing these briefs & exhibits.  And also thanks to the anonymous silicone sister who put them up on the SiliconeCity website for us.

http://www.homestead.com/siliconecity

 

SEE LINKS TO NEW WEBSITE INFORMATION BELOW.

 

The "Dow Plan" -- could infer Dow Corning or Dow Chemical -- seems fitting,

since some attorneys refer to it as the "Dow Chemical Bankruptcy Plan."

All of us claimants are certainly more than tired of the many years we have

been waiting for compensation, yet "big money" and certain politicians who

support this, still influence our government and our public at every

opportunity they can to make our litigation a dirty word. Why isn't it that

"litigation" simply equals "compensation" to the injured? All I can say is,

we must watch who we vote for, or we might be taking an action that would be

as bad as a friend says, being "a chicken and voting for Colonel Sanders!"

It seems to me, when it comes to our rights on this issue of silicone breast

implants and devices, this is not about the supposed term "big government."

Quite the opposite. In our issue, the only thing that is big, is "big money"

supporting politications.

 

Moving beyond that point, the Dow Corning Plan, and these Confirmation

proceedings, are ever confusing. It is very hard to understand what is going

on at this Appellate stage right now, making it even harder to figure out,

accurately, regarding what legal theory any claimant would support or want.

There is one thing I know ALL of us injured parties do want -- compensation

that is better than, what Nevada Attorney Geoff White's most recent email

referred to, MOST claimants receiving $10,000, $20,000 or $50,000 for a

LIFETIME of disease, disability and destroyed lives. (This number is without

the almighty racheting down of listed compensation amounts that could very

well occur in the Dow Corning Plan. The Dow Plan has no GUARANTEE as the

class-action Revised Settlement Program (RSP) had).

 

So, why would anyone (unless they were mislead) want to write the TCC, the

Plaintiffs Steering Committee, Judges Pointer, Kennedy and Andrews, or anyone

else, and tell them they want the Plan to go through if it is slated to pay

the majority of us injured people only $10,000, $20,000 or $50,000 for our

diseases? And worse yet, these amounts could be racheted down, and there are

hidden qualification requirements that can prevent claimants from being

compensated anywhere near what they expected. According to statistics, among

these three Option I disease compensation categories, 40% will get $10,000,

another 40% will get $20,000, and only 20% will get $50,000. As described

further below, less than 800 women have ever qualified in the RSP for the

Long-Term (equal to Dow's Option II) diseases. If I could make a giant

billboard to point this out, I would.

 

Even the RSP had it's tricks, after all, 80% of those who applied for

Long-Term, like Dow's Option II, disease categories were DENIED. Why? I

believe the trick I refer to as the "24-month window" requirement was the

reason in the RSP, and it's in the Dow Plan too. See my Post-Hearing Reply

Brief about this, and I will be glad to send you by email only, a copy of the

exhibit which shows the high denial rate. As of the date of the exhibit,

2,225 women filed claims in the upper end of the disease grids, Long-Term

(like Dow's Option II) and only 637 qualified. Only one hundred or so more

have ever qualified, yet a tremendous number of women tend to look at those

grids and believe they will qualify.

 

More information can be gained about all of this by looking at the problems

that are pointed out about the Plan at the Silicone City website as linked

below. Since so many of us take the time to read so much that is available

on the Internet, I hope parties-in-interest in this Plan, for the sake of

their own awareness (and nothing more from my end, as my appeal is my own

choice and right), will take the time to read over the information and take a

look at the actual Plan Disclosure Statement and see some updated

perspectives about it.

 

It would be very helpful to get a copy of Annex A, if not already in hand,

which can be requested by contacting the sources referred to at the TCC

website, or by viewing Annex A online. It can be viewed (with Adobe Reader)

at the TCC website by clicking the words on the left column of the home page

-- "Plan Documents," and then scroll down PAST "Plan Documents" (would you

believe) and choose "Underlying Documents" and then choose "SFA_annex_a.pdf"

- Annex A to Settlement Facility and Fund Distribution Areement (Claims

Resolution Procedures):

 

LINK (can click while online) -- <A HREF="http://www.tortcomm.org/">Tort

Claimants Committee</A>

WEB ADDRESS -- http://www.tortcomm.org/

For numerous reasons on appeal, this Plan will very possibly be remanded back

to Judge Spector for a required review of the adequacy of funding and perhaps

for modifications regarding this, and other important issues as to fairness.

It would not take long to come out with ONE MORE PLAN which could be made

many times better than this one. It could be that the much needed

modifications to the Plan would not even require a new vote, which is allowed

ONLY if the modifications are positive and advantageous to the creditors.

Regarding fear tactics and threats that there could be NO Plan: There MUST

be a Plan. There is not the threat of having no Plan, in my opinion, because

no matter what the current litigation climate is, at least 20,000 cases will

be set for trial and approximately 70,000 currently ill claimants will be

ready for a CLASS-ACTION without the bankruptcy. This is the situation. We

are Ok, and there will be a Plan soon, one way or another.

 

[A necessary disclaimer here: I must say, this and anything I have written

here, is my opinion, and I cannot be responsible for anyone's personal

decisions. Anything that I say, if it is relevant to you, should be pursued

and confirmed by you regarding any personal decision making].

None the less, there are TWENTY-SIX (26) Appeals of this case before Judge

Hood, so that no individual appeal is responsible for delays overall. It is

amazing that another one of Dow Corning's self-made rules in the Plan is that

the only matter that can hold the Plan up is an appeal regarding the

third-party release. (See the Plan Disclosure Statement on page 69, "6.5 -

Conditions Precedent to Confirmation." On page 70, section (B)(1) - "No

timely-filed appeal shall have been taken from the Confirmation Order

challenging directly, or indirectly, the validity and enforceability of the

releases ...").

 

.... Amazing - as if they want to make it that all other appeals are moot.

This can be seen by looking at the Disclosure Statement and reviewing the

rest of the criteria at section 6.5. Judge Spector has on three occasions

since June 1999 overextended finances for implementation of the Plan -- very

prematurely. (This is discussed in the Opening Brief on Appeal and in the

Opposition to CMO). Fortunately, there are laws that prevent moving the Plan

forward until it has passed the muster of bankruptcy plan confirmation rules.

(Just pointing out here some of the interesting actions that have been going

on surrounding these appeals).

 

[Note: It is difficult to understand these points when opposing argument is

relayed, as these statements can be legally argued back and forth. An

opposing view can go on and on using legal style debate to try to flip the

perspective on what I am saying. Do keep this in mind. Reading the brief,

where case-specific facts are additionally referred to on the CMO, or other

appeal issues; a person can be better armed with additional facts, no matter

which perspective is adopted].

 

You can find out about the Dow's attempt to advance the Plan, regardless of

Appeals at the Silicone City website, indicated below. (BTW: Now the Dow's

want the delay also because PaPa Dow Chemical is unhappy with Judge Spector's

December 21, 1999 Opinion giving a partial non-release to those who voted no

or who abstained from voting).

 

Information regarding the appeals, is available at a NEW web posting of my

Opening Brief on Appeal. There is also a brief posted at the site about the

"CMO" - Case Management Order, which was submitted to Judge Hood by Dow

Corning.

 

The documents are available at the Silicone City website. After you go to

the Home Page, look further down the page for "Marti Jacobs - Dow Appellate

Brief Material (New)." There will be links to the documents from that site.

Silicone City is located at:

 

LINK (can click while online) -- <A

HREF="http://www.homestead.com/siliconecity/index.html">index</A>

WEB ADDRESS -- http://www.homestead.com/siliconecity/index.html

 

LET RIGHT BE DONE, AND EQUITY FOR ALL WHO ARE INJURED.

 

Peace, Love & Justice,

Marti Jacobs

Tempe, Arizona

( A claimant in the Dow Plan who has filed an Objection and now an Appeal)

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Consorting with the Enemy
What the Plaintiffs Bar Plans for '98

Note: This publication is designed to provide timely and accurate information regarding medical product liability claims and litigation. It is not designed to offer legal advice. If legal advice or expert assistance is needed, the services of a competent professional should be sought. Jeffrey Singer Esq. Segal McCambridge Singer & Mahoney, Ltd. Editor's Note: Jeff Singer is an experienced member of the MEDMARC Defense Attorney Network who has represented the Company and medical device firms for over a decade in one of the country's toughest jurisdictions. We give this issue over to him as a forum for relating findings from a recent plaintiff-oriented conference he attended on medical device litigation. In war, as in litigation, it is critical to "Know thy enemy." Recently, I spoke at a drug and medical device litigation seminar sponsored by Mealey Publications. Mealey Publications generates newsletters on medical device and pharmaceutical lawsuits. Its readers and audience typically consist of attorneys who prosecute or defend medical devices and pharmaceutical product liability lawsuits. As a defense lawyer, I have attended dozens of product liability legal seminars over the years. Many are dull and provide little meaningful new information. However, Mealey's seminar was more interesting. 1997 saw a significant number of new developments in drug and medical device product liability litigation. Several more breast implant cases went to trial. Pedicle bone screw litigation was as active as ever. Norplant litigation boomed. Latex glove allergy litigation tripled in size, causing me to question, "What else will the device industry have to contend with in 1998?" 1998 may become a watershed year for the Plaintiffs' bar and the medical device industry. There appears to be a pendulum swing of public opinion which may be moving in favor of the medical device and pharmaceutical industries. For example, breast implant litigation has become an embarrassment to the plaintiffs' bar and the FDA. Trial after trial in 1997 saw juries unconvinced that silicone-gel breast implants played any causal role in developing auto-immune or connective tissue disease. State and federal court juries in 1997 found "no defect" in several breast implant cases notwithstanding the fact that the FDA called for a ban of silicone gel breast implants in 1992. Latex Glove Litigation 1997 also brought latex glove allergy litigation. Plaintiff attorneys who eventually became the "Lead Counsel" for the Plaintiffs before the Federal Multi-District Litigation Court earlier argued to the Judicial Panel for Multi-District Litigation that he expected over 10,000 latex glove allergy cases would be brought in the coming months. Other plaintiff attorneys publicly boasted that each had five hundred to one thousand latex glove allergy cases about to be filed in their home jurisdictions. Those forecasts, of the filing of a large mass of cases, proved to be mere puffery. By December of 1997, only 185 cases had been brought. Clearly, not the avalanche of cases which the plaintiffs' bar had predicted to the Court and media. Expert Debacle in Pedicle Screw Cases Further embarrassing the plaintiffs' bar was the 1997 disclosure that one of its experts in pedicle bone screw litigation may have perpetrated a grotesque fraud upon the court. This "expert" supposedly prepared over 400 expert reports for existing cases, submitting them as his own work product. However, during the deposition of a clerical person, it was learned that many of the reports were not authored by this expert but instead by a man employed by an expert witness brokerage service in Sherman, Texas. The expert's broker is alleged to have actually ghostwritten hundreds of reports; and later submitted them as having been authored by the plaintiff's expert. An effort to destroy or erase the broker's dictation tapes almost proved successful -but a few were preserved. Thus, 1997 was not a vintage year for the Plaintiffs' bar -making 1998 all the more ominous. Plaintiff Marketing Tactics Mealey's Drug and Medical Device seminar consisted of much self-promoting "marketing" by members of the plaintiffs' bar who actively litigate cases against device manufacturers. It became evident that the plaintiffs' bar faces extreme competition from within. In fact, it appears that some Plaintiffs' attorneys have chosen to become more adept working with the public relations firms they retain than prosecuting their cases. Instead of waiting for a client to call, some Plaintiffs' attorneys instead actively "reach out" to would-be "victims" of a device or pharmaceutical. Latex Glove Litigation Latex glove allergy litigation is a prime example. Law firm Internet Web pages, client-seeking newspaper ads, TV commercials, and seminar presentations directed to a very specific audience of potential clients (e.g., nurses and dental hygienists) have been nothing more than concerted efforts to gain new clients before another member of the plaintiffs' bar gets to that "victim" first. Fen-Phen Litigation Competition amongst the plaintiffs' bar became obvious to those who closely listened to the plaintiff attorneys who made presentations at the Mealey's Drug and Medical Device Litigation seminar. Significant time was spent on the "new" mass tort: fen-phen pharmaceutical litigation. While this does not involve device makers, it is instructive. Within 120 days after the Mayo Clinic published a report regarding possible heart valve problems from the concomitant consumption of fenfluoramine, dexfenfluoramine, and phentermine, nearly two hundred lawsuits were brought in state and federal courts around the United States. Yet, the scientific community and the FDA are as yet unsure if, in fact, there exists a causal relationship between these medications and the onset of heart valve and/or primary pulmonary hypertension problems. Moreover, those hypothesizing a causal link do not know why this occurs. Then, why are so many lawsuits being filed before the science is developed? The answer is, unfortunately, due to the competition for cases. Several plaintiffs' attorneys engage in active efforts to develop a reputation as "the specialist" in this complicated litigation - and try to create this image by extraordinary self-promotion. The more cases he files - the more "credibility" attaches. Like breast implant litigation and latex glove allergy litigation, fen-phen has become the "mass tort du jour". But the public and the Courts may be getting tired of the Plaintiff bar's incessant promotion of these "public health crises." Tort reform legislation has been approved in several states throughout the nation, appellate court rulings have been issued barring certain settlements of mass tort claims and several lower and higher courts have barred a class action as a form of relief for certain mass tort litigation. These efforts reveal a pendulum swing may be occurring, revealing that many disfavor what has been the status quo for several years. Implications for Device Companies Yet, this turn of events may make these guys (and gals) even more dangerous. More self-promotion, more aggressive solicitation tactics and even less investigation of the relative merits of a claim before filing suit should be expected in the coming years. This is ominous for medical device manufacturers. Closer attention must be paid for device research and safety development. More explicit documentation of product safety testing must be made; and complete disclosure of all known and even potential hazards of device usage is necessary to better support your defense for the courtroom. Coordinating Defense with Doctors One portion of the Mealey's seminar dealt with effective prosecution of the medical malpractice and medical device case. Plaintiffs' attorneys trying to nurture hostility between the defendant physician and the defendant device manufacturer regarding the adequacy of the device's instructions for usage and disclosure of the potential risks of injury to the patient. While MEDMARC defense lawyers recognize the importance of having a unified defense with a defendant physician, the Plaintiffs' bar is making it no secret that they will reward the defendant physician with a voluntary dismissal or an inexpensive settlement if that physician openly attacks the device manufacturer. This has occurred in breast implant litigation. The device manufacturer generally has more insurance than the physician - as well as a wider base of assets if insufficient insurance coverage exists. Thus, the device manufacturer is at risk not only from the plaintiffs' case but the co-defendant physician as well. Federal Pre-Emption Defense A portion of the Mealey's seminar also dealt with an update on existing device litigation. Presentations were made on the status of latex glove allergy litigation, pedicle bone screw litigation, pacemaker litigation, and breast implant litigation. But if there was a subject at the seminar which appeared to pose the greatest concern to the Plaintiffs' bar, it was the presentation on "Federal Preemption". During late June of 1996, the United States Supreme Court issued an opinion in a case entitled Medtronic V. Lohr, That questioned whether the defense of federal preemption could be applied to bar a product liability lawsuit brought against a device manufacturer whose device was authorized to be marketed pursuant to a 510(k) application. The Supreme Court held that 510(k) devices are not immune from product liability lawsuits. However, because of ambiguous language in the Supreme Court's opinion, a question still exists whether Federal Preemption could apply to bar product liability lawsuits involving IDE and PMA devices. A mock appellate argument on Federal Preemption was presented by a member of the Plaintiffs' and the defense bar involving a fictional IDE device case. Based on questions posed by certain plaintiff attorneys in the seminar audience and during informal talks I had with a few of them, there is no question Federal Preemption is a major concern for the plaintiffs' bar. In sum, consorting with the enemy at the Mealey's seminar provides a better view of some of the challenges a plaintiff's attorney faces today. The competition for cases appears immense -- even though, sadly, there is no shortage of potential clients willing to bring a lawsuit. Many Americans are all too willing to bring a lawsuit. Notwithstanding this, the plaintiffs' bar still feels it must self-promote on a national or local scale to preempt other plaintiffs' attorney "specialists" from getting these clients. This makes the litigation environment for a device manufacturer even more precarious. Medical Device Claims Newsletter is published quarterly by MEDMARC Mutual Insurance Company, 4000 Legato Road, Suite 800, Fairfax, VA 22033. Phone: (800)356-6886 Fax: (703)385-3725

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http://www.pbs.org/wgbh/pages/frontline/implants/corp/pkginserts.html

(Statement from the Dow Corning Corporation, September 1995)

Context:
As new research on breast implants is discrediting accusations linking the devices to immune system disease, older accusations are being recycled that Dow Corning failed to disclose the complications involved with breast implants and breast surgery until "forced" to do so as a result of an unfavorable 1984 legal verdict. As a result, the critics maintain, women did not have sufficient information to make an informed decision.

Summary:
In fact, Dow Corning's disclosures to surgeons on breast implant complications track with information on the devices published in the medical literature. The company disclosed the evolving information on breast implant surgical procedures and potential complications to the medical community through vehicles like package inserts, data sheets, and surgical technique brochures. Like most medical device manufacturers, the company relied on patient information being conveyed through physicians. In fact, physicians strongly maintained that direct communication by the company to patients was inappropriate and potentially interfered with the doctor/patient relationship.

Excerpts from Dow Corning's Package Inserts and Information Sheets:

These excerpts show changes through the years in Dow's package inserts and information sheets concerning silicone breast implants. The issue of 'Informed Consent' --whether or not women were informed of the risks or complications from silicone implants and how long they would last--is a central one in the implant controversy.

Dow Corning Cronin Technique for Implanting, Package Insert 1965

NOTE: Extensive laboratory and clinical studies have established that advantageous properties, limitations and surgical applications for medical-grade silicone elastomer implants. All synthetics, however, raise presently unanswerable questions with respect to the absolute safety of long term implantation in humans. Regarding the question of neoplasms in general implant situations. Brown states "We have not seen tumors in 100 clinical uses of synthetic materials, and the silicone and fluorocarbons have shown less tissue reaction than polyvinyl alcohol. The possibility of tumor formation around synthetic implants in animal experiments should be explained to patients in whom synthetic material is to be considered. The explantation should include the situation that these synthetics are so new that there has not been time to follow any such implants through a full human life-cycle. The advantage of synthetics possibly outweighs the inference that tumor formation in laboratory animals implies a significant risk of clinical use of medical-grade synthetics."

• Dow Corning "Facts You Should Know About Your New Look", 1970-1975

  Your physician has given you this booklet to help you understand the Mammary Prosthesis. There are probably countless questions you'd like answered about this surgical procedure. All of them can't possibly be covered here. But this booklet can give you a general picture of what's involved, drawn from the experience of doctors, clinicians and women who have had Mammary Prosthesis implantation.

  Q. How long will the Mammary Prosthesis last?
  A. Based upon laboratory findings, together with human experience to date, one would expect that the Mammary Prosthesis would last for a natural lifetime. However, since no Mammary Prosthesis has been implanted for a full life span, it is impossible to give an unequivocal answer.

  Q. Can I expect any problems with my breasts following mammary augmentation?
  A. While thousands of women have mammary augmentation operations done annually without any adverse reactions, no surgical procedure is a success every time, and each person's reactions to surgery and implantation can be different. Occasional complaints of excessive breast firmness and/or discomfort caused by fibrous capsule formation and shrinkage have necessitated surgical correction and have been noted in the medical literature.
  

• Dow Corning package insert 1973

  NOTICE IMPORTANT INFORMATION
  This design of SILASTIC Round Mammary Prosthesis is new when compared to prior design. However, because of the thinner envelope design, this prosthesis is also somewhat more fragile than prior designs. It is especially important that the package insert provided with this device be read carefully and in its entirety. It is necessary that due care be exercised during the surgical procedure as to not rupture the prosthesis. A thorough study of the information provided and exercise of due care in handling this device should result in no problem for the surgeon. However, since Dow Corning realizes that accidental rupture of the device could occasionally occur, it is recommended that an extra pair of the same size prosthesis be available at the time of surgery. In addition, Dow Corning is presently maintaining a policy of no charge replacement of the prosthesis should it be accidentally ruptured by the surgeon during operative and surgical use...ruptured prostheses should be retained for replacement by your salesman.

   

• Dow Corning Fact Sheet 1976

  Fibrous Capsule Contracture
  It has been recognized for many years that capsular contracture occurs in some augmentation mammoplasty patients. Hormones, gel "bleed", silica, dust, talc, surgical procedure, pocket size, fill levels, patient type, electrostatic charges, and many other suggestions have been offered as possible explanations for this phenomenon. No generally accepted explanation exists today. There is also no universally accepted method of preventing fibrous capsule contracture.

  Gel-filled silicone implants slowly "bleed" minute quantities of silicone, which has been detected in the fibrous capsule. The presence of this silicone does not correlate with the clinical hardness of the capsule.
  

• Dow Corning Suggested Surgical Procedure 1976, 1979, 1980

  Adverse Reactions
  While thousands of women have mammary augmentation operations done annually without any adverse reactions, no surgical procedure is a success every time, and each person's reactions to surgery and implantation can be different. Occasional complaints of excessive breast firmness and/or discomfort caused by fibrous capsule formation and shrinkage have necessitated surgical correction and have been noted in the medical literature. An alternative to surgical release of a "tight" capsule is the closed compression technique for rupturing a contracted capsule around a breast implant.

  Excerpt from "Instructions for use:"
  5. Be certain that the patient understands that following implantation, abnormal squeezing or trauma to the breasts could conceivably rupture the implants.

  
  Dow Corning "Facts You Should Know About Your New Look", 1977, 1978, 1979

  Q. How long will the Mammary Prosthesis last?
  A. Based upon laboratory findings, together with human experience to date, one would expect that the Mammary Prosthesis would last for a natural lifetime.

 

• Dow Corning "Facts You Should Know About Your New Look", 1980

  Q. How long will the implants last?
  A. Based on laboratory findings and human experiences to date, a gel-filled breast implant should last for a lifetime. However, since gel-filled breast implants have been implanted since 1962, there is only approximately 20 years of actual experience. Saline-filled and gel-saline implants have been used for 10 years and 5 years respectively. These may or may not last as long as gel-filled implants. They may also leak and subsequently deflate.

 

• Dow Corning package insert 1980

  Excerpt from "Complications"
  7. Capsule contracture
  As noted in the medical literature, complaints of excess breast firmness and/or discomfort caused by fibrous capsule formation and shrinkage have necessitated surgical correction.
  

• Dow Corning package insert 1983

  Note
  The medical literature indicates that the functional life of any implant may not exceed the lifetime of the patient. This should be explained to and understood by the patient, by the physician.

  Complications:
  11. Closed Capsulotomy
  Closed capsulotomy may rupture mammary implants.

  12. Calcification
  Reports of calcium plaques on or surrounding mammary implants have been reported in a few cases. No evidence is presented in the literature to link the prosthesis with calcification.

  13. Silicone migration
  Closed capsulotomy procedures may rupture the implant and necessitate removal. Under severe force the envelope can rupture and silicone gel can be forced out of the implant into natural body planes.

  The above mentioned reactions should be discussed with and understood by the patient prior to surgery.

   

• Dow Corning package insert 1985

  Possible Adverse Reactions and Complications
  Thousands of women per year have had cosmetic or reconstructive surgery with implantation of mammary prostheses. A number of patients are reported to have significant complications or adverse reactions. Typically, any patient undergoing a surgical procedure is subject to unforeseen intra-operative and post-operative complications. Each patient's tolerance to surgery, medication and implantation of a foreign object may be different. Possible risks, adverse reactions and complications associated with surgery and the use of the mammary prosthesis should be discussed with and understood by the patient prior to surgery. The adverse reactions and complications most likely to occur with the use of this product are listed below. IT IS THE RESPONSIBILITY OF THE SURGEON TO PROVIDE THE PATIENT WITH THE APPROPRIATE INFORMATION PRIOR TO SURGERY.

  1. Capsule Formation and Contracture
  The post-operative formation of a fibrous tissue capsule around the mammary prosthesis is a normal physiologic response to the implantation of a foreign object. Capsule formation occurs in all patients. However, each patient capsule will vary in degree, ranging from thin and filmy to heavily thickened. Contracture of a fibrous capsule may occur, independent of its thickness, resulting in discomfort, pain, excessive breast firmness, a palpable prosthesis, and/or displacement of the prosthesis. The medical literature documents that correction may require intervention by the surgeon. In some patients, even with further surgery and treatment by the surgeon, firmness may recur. This possibility should be discussed with and understood by the patient prior to surgery. Integrity of the envelope cannot be assured if the surgeon should choose to perform closed capsulotomy, i.e. if external force is used in manual compression of the breast, since unknown or abnormal force may be applied to the implant. Such abnormal trauma or stress to the breasts could result in prosthesis rupture and extravasation of gel into surrounding tissue.

  2. Sensitization
  There have been reports of suspected immunological sensitization or hyperimmune system response to silicone mammary implants. Symptoms claimed by the patients include localized inflammation and irritation at the implant area, fluid accumulation, rash, general malaise, sever joint pain, swelling of joints, weight loss, arthralgia, lymphadenopathy, alopecia, and rejection of the mammary prosthesis. Such claims suggest there may be a relationship between the silicone mammary implant and the reported symptoms. Materials from which this prosthesis is fabricated have been shown in animal laboratory tests to have minimal sensitization potential. However, claims from clinical use of the silicone prosthesis in humans suggest that immunological responses or sensitization to a mammary prosthesis can occur. If sensitization is suspected and the response persists, removal of the prosthesis is recommended along with removal of the surrounding capsule tissue. This procedure is recommended along with removal of the surrounding capsule tissue. This procedure is recommended to minimize the amount of residual silicone that may be left at the implant site.

  3. Implant Rupture and Gel Extravasation
  Rupture of implants has been reported both intra- and post-operatively. Rupture may result from the following: intra- or post-surgical trauma; excessive stresses or manipulation as may be experienced during normal living experiences including routine and purposeful trauma as vigorous exercise, athletics and intimate physical contact; mechanical damage before or during surgery or other unknown causes at the site of implantation. Chronic flexing of the implant shell during use as may be experienced during the performance of routine manual massage or manual exercise of the implanted breast may also produce long term fatigue of the shell, resulting in rupture. If the surgeon should choose to perform manual compression of the breast (closed capsulotomy) he/she should be aware that it may lead to implant rupture due to weakening of the envelope from the continued and excessive forces the implant may experience. The patient should be adequately informed of the possibility of implant rupture with the use of this technique and of the necessity to remove a ruptured implant should that occur. Dow Corning is not responsible for the integrity of the implant should such techniques as closed capsulotomy (manual compression) be performed. Medical reports state more frequent intra-operative rupture occurs with the use of a small incision for introduction of the prosthesis, as in trans-axillary insertion, or in submuscular placement of a prosthesis. As reported in the literature, when an implant ruptures, gel may be released from the implant envelope despite the cohesive properties of the gel. If left in place, complications such as enlarged lymph nodes, scar formation, inflammation, silicone granulomas and nodule formation may result. Possible further migration of the silicone gel to other tissue as well as adjacent tissue may occur. A limited preliminary study has been reported to the medical community that in the presence of select bacterial infection at the site of a ruptured implant, extravasated gel may be altered by the bacteria with a resultant decrease in cohesivity of the gel. If true, there is greater potential for distant migration of the gel. In the event that a ruptured prosthesis is suspected, and especially if the area becomes infected, Dow Corning recommends removal of the envelope and gel. These potential consequences should be understood by the surgeon and explained to the patient prior to implantation.

  Note:
  Dow Corning's high performance medical-grade silicone elastomer has been used to fabricate the envelope of this implant. This material can be cut by a scalpel, penetrated by a needle, damaged or ruptured by excessive stress, intra-operative manipulation, or by instruments. The silicone gel within this product is formulated and cured to maintain cohesion and minimize migration of gel should the envelope rupture. In the event of a rupture, Dow Corning recommends prompt removal of the envelope and gel. The long term physiological effects of uncontained silicone gel are currently unknown. Since SILASTIC II Mammary Implant H.P. is composed of alloplastic materials, it is subject to possible reactions and complications as listed above. Therefore, the patient should not be lead to unrealistic expectations as to the performance or cosmetic results that the surgery and prosthesis can provide. The patient should be informed that the life expectancy of any implant is unpredictable.

  15. Implant Gel Bleed
  Gel bleed results from the passage of small quantities of silicone through the elastomer envelope of the implant. In vitro bleed tests demonstrate that this bleed phenomenon is significantly reduced in the SILASTIC II prosthesis. The detector of small quantities of silicone in the tissue adjacent to the intact, conventional gel-filled implant and in axillary lymph nodes has been reported in the medical literature. There is no evidence of metabolic products of this silicone bleed. Some cellular reaction around the implant may be expected as normal foreign body response.

  16. X-ray Pre-Operative and Post-Operative

  17. Calcification
  Physicians have reported calcification of the tissue surrounding the implant. The etiology of calcification is unclear. In some instances, heavy calcification resulting in local discomfort and breast firmness may require removal of the implants and the calcified capsule. 18. Absorption of Biologicals by Implants Selected breast prostheses examined after various lengths of implantation have undergone a change in the gel and envelope coloration to shades of yellow. Occasionally, the gel has been observed to contain particles that include material of varying size, texture, and coloration. Analysis have revealed many to contain triglycerides, lipids, or steroid-type materials. These are postulated to slowly move through the silicone elastomer shell from the surrounding tissues. The degree of such biologicals appears to be patient-specific.

 

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OTHER SILICONE RELATED RESOURCES ARE AVAILABLE THROUGH
THE SILICONE WEBRING

http://www.homestead.com/siliconecity /webring

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WHERE THERE’S SMOKE THERE’S FIRE ~ On The Net
The following websites have the “Where There’s Smoke There’s Fire” documents:

http://implants.clic.net/tony/Smoke/index.html

http://www.homestead.com/siliconecity/index.html

http://implants.clic.net/tony/Smoke/index.html

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Dow Docs - Online

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LOOKING FOR BACK ISSUES OF THE WOMEN’S IMPLANT SUPPORT NEWSLETTER?
Back issues of our Newsletters are archived and available on the Tony and Micheline Lambert’s website, “Canadian Connection.”

http://implants.clic.net/tony/Myrl/index.html

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HUMOR
This humor has been sent to us by Chris. . .Thank you Chris.

This is purported to be a true story someone found regarding exams at

Cambridge University. It seems that during an examination, a bright

young student popped up and asked the proctor to bring him Cakes and

Ale.

 

The following dialog ensued:

 

Proctor: I beg your pardon?

 

Student: Sir, I request that you bring me Cakes and Ale.

 

Proctor: Sorry, no.

 

Student: Sir, I really must insist. I request and require that you

bring me Cakes and Ale.

 

At this point, the student produced a copy of the four-hundred-year-old

Laws of Cambridge, written in Latin and still nominally in effect, and

pointed to the section which read (roughly translated):

 

"Gentlemen sitting examinations may request and require Cakes and Ale."

Pepsi and hamburgers were judged the modern equivalent, and the student

sat there, writing his examination and happily slurping away.

 

Three weeks later, the student was fined five pounds for not wearing a

sword to the examination.

 

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