Aging of Implants : A Timeline of Silicone

THE AGING OF IMPLANTS A Timeline of Silicone Implant Court Cases 1960 1962 Frank Gerow and Thomas Cronin develop the first silicone breast implants. [1] Timmie Jean Lindsey is the first to go under the knife for the implants. [1] 1976 Breast implants are labeled Class II, meaning each product requires premarket approval by the FDA. [2] Silicone implants have already Congress passes the Medical Device FDA been on the Amendments to the market and are Federal Food, Drug and Cosmetic Act. grandfathered in. [1] 1977 1982 Dow Corning pays $170,000 The FDA proposes the upgrade of silicone breast implants to Class II category, meaning they must be proven safe in order to remain on the market. [1] SAFE in the first lawsuit for a ruptured implant. [1] 1984 Maria Stern is awarded 5 $211,000 in compensatory damages This is the first time the relationship between autoimmune disease AND and silicone implants is $1.5 MILLION introduced. in punitive damages from Dow Corning by a jury that found that her silicone breast implants caused A court order seals all evidence. [1] her autoimmune disease. 1988 1991 The FDA acts on its 1982 proposal and upgrades implants to Class III, setting a due date of July 1991 for scientific proof that they are safe. A jury awards Brenda Toole a $5.4 MILLION settlement against Baxter/Heyer-Shulte after witnesses report finding silicone in her lymphatic system. [1] SEPTEMBER NOVEMBER DECEMBER Mariann Hopkins wins The FDA assembles the General and The FDA finds data submitted by implant manufacturers to be inconclusive and asks for further research. [1] $7.3 MILLION Plastic Surgery Devices Panel, which asks for more safety data. (1] against Dow Corning when her lawyer links her ruptured silicone breast implants to her mixed connective-tissue disease. [1] By this time, there are 137 SUITS filed against Dow Corning. 1992 The General and Plastic I Surgery Devices Panel recommends limiting implants for reconstruction and that women receiving JANUARY FEBRUARY them be studied for risks of autoimmune disease. [1] Manufacturers agree to a voluntary moratorium on distributing new implants pending FDA consideration. [1] Stan Chesley files a class action lawsuit The panel finds no causal link between autoimmune in an effort to help women more quickly than filing individually. (1] disease and silicone breast implants. (1] MARCH DECEMBER By this time, there are 3,558 SUITS Dow Corning, Bristol-Myers Squibb, and Bioplasty all decide to no longer Pamela Jean Johnson is awarded suits filed against Dow Corning. [1] $5 MILLION in actual damages and manufacture silicone breast implants. (1) $20 MILLION in punitive damages from Bristol-Myers Squibb by a jury who finds her ruptured implants were linked to several medical symptoms, including mixed connective-tissue disease, chronic fatigue, and joint pain. [1] 1993 DECEMBER 1994 There are now A jury awards 3 Houston 12,359 women a total of individual suits $27.9 MILLION filed against Dow Corning. [1] from 3M for their silicone-implant-related autoimmune illnesses. [1] X19K MARCH DECEMBER 19,092 The class action It is the largest class- action suit in history, at lawsuit filed in 1992 finalizes, bringing in Baxter, Bristol-Myers Squibb/MEC, and ЗМ. [1] lawsuits are now filed against Dow Corning. $4.2 BILLION. 13] 1995 X20K FEBRUARY Gladys Laas is awarded $5.2 MILLION by a jury that found Dow Corning guilty of deceptive practices. Dow Corning is now facing and approximately Her husband is awarded 400,000 $1 MILLION 20,000 claims in the class action settlement. [1] for loss of consortium. [4] individual lawsuits X13K MAY OCTOBER DECEMBER Charlotte Mahlum Dow Corning files for Chapter 11 bankruptcy, effectively halting litigation. [1] There are now is awarded $13.9 MILLION in the first trial to name Dow Chemical (the parent company) as the sole defendant. (1] 13,000 individual suits against Dow Chemical. (1] 1998 Dow Corning settles several injury claims with a $3.2 BILLION offer. This allows Dow to halt bankruptcy proceedings. [1] NOVEMBER DECEMBER Dow Corning files for reorganization and offers payout options to claimants. [1] Nevada Supreme Court upholds the $41 MILLION awarded to Charlotte Mahlum for her compensatory damages but overturns a $10 MILLION 1999 punitive award. (1) 2012 Dow Corning continues to pay for implant complications. nhinlin An attorney wins a $10 MILLION settlement against Bristol-Myers Squibb for her claim that implants caused her scleroderma. [1] Cumulative payments through January 2012 amount to $1,264 BILLION. 15) SOURCES [1] http://www.pbs.org/wgbh/pages/frontline/implants/cron.html [2] http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/ breastimplants/ucm064461.htm [3] http://articles.sun-sentinel.com/1994-11-24/news/9411220519_1_dow-chemical-dow- corning-gel-filled-breast-implants [4] http://www.pbs.org/wgbh/pages/frontline/implants/legal/plaintiffargue.html [5] http://www.sfdct.com/tasks/render/file/?fileid= 010a2f9b-c5e4-4082-9c4e91bd47f934f0