My Breast Augmentation Journey
I have one of the styles of implants that have been recalled and in the light of all the evidence, I have chosen to keep my implants. My decision is partially based on my trust in my consultant and his ethics.
FDA.
The FDA is not recommending the routine removal of these or other types of breast implants in patients who have no symptoms. https://www.fda.gov/
To put the current statistics into perspective the risk of getting BIA-ALCL with Allergan implants is extremely low, with the percentage chance being 0.026%.
In comparison, the risk for any women being diagnosed with breast cancer is 12% (U.S.A) and 14% (UK).BREASTCANCER.ORG https://www.cancerresearchuk.org/
- Know the symptoms of BIA-ALCL – primarily persistent swelling or pain near the breast implant – and monitor the area around your breast implants for any changes.
- If you experience any of these symptoms or other changes, talk to your health care provider regarding the need for further evaluation. Evaluation for BIA-ALCL typically involves a physical exam, imaging, and/or assessment of the fluid or tissue around the breast implant. It is important to undergo an evaluation to diagnose BIA-ALCL since a confirmed BIA-ALCL diagnosis may change the type of operation that should be performed.
- Based on discussions with your health care provider, patients with confirmed BIA-ALCL should undergo implant removal and removal of the surrounding scar capsule, which is a more extensive operation than implant removal alone.
- As with any implanted device, it is good to keep a record of the device manufacturer, a unique device identifier, and implant model name. You may have received this information on a patient device card from your surgeon. If you would like to obtain any of this information, consider asking your surgeon or obtaining the record of your surgery (operative notes) from the facility where it was performed.
- Understand that most cases of BIA-ALCL occur many years after breast implant placement. Talk to your surgeon about your risk of developing BIA-ALCL.
Breast Cancer.
Breast cancer is the most common cancer in the UK and 8% of cases each year are caused by drinking alcohol. The risk increases even at low levels of drinking.
https://www.cancerresearchuk.org/about-cancer/causes-of-cancer/alcohol-and-cancer
I respect that this is a very personal decision and if you feel your consultant has been negligent in advising about the link between Allergen Implants and ALCL you may want to seek legal representation.
Global Recall.
This global recall does not affect Allergan’s NATRELLE® smooth or MICROCELL® breast implants and tissue expanders.
The recalled products include:
- Natrelle Saline breast implant styles 168, 363, 468
- Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle 510 Dual-Gel styles LX, MX, FX
- Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
- Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch
- Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM
- Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
- Natrelle 150 Full Height and Short Height double lumen implants
- Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV,
- T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
- Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX,
- 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T
ALLERGENS STATEMENT
July 30th, 2019, Allergan announced it would cover the costs of new implants for people with Biocell implants who want to replace them. Allergan won’t pay for surgery costs, however. The program runs until July 24, 2021.
Law Suits:
UK/USA/CANADA/AUSTRALIA/WORLDWIDE
There have been a number of class actions and lawsuits filed against Allergen, I have listed below the current information available on this to date.
In the U.K, the recently launched Breast and Cosmetic Implant Registry (BIR) also affords opportunities for registering cases of BIA-ALCL. The BIR was primarily designed to record the details of any individual who has breast implant surgery for any reason so that they can be traced in the event of a product recall or other safety concern relating to a specific type of implant, and requires explicit patient consent.
You may also wish to register your case with the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE), a registry launched in the U.S. several years ago in conjunction with the FDA.
https://associationofbreastsurgery.org.uk/
January 2019, Investors have filed a class-action lawsuit against leading breast implant manufacturer Allergan, alleging that the company concealed from them both the association between textured breast implants and a rare form of cancer and the threat this link posed to Allergan’s regulatory approvals.
UK
July 2019, Leigh Day is this week to send letters to the manufacturer and clinics who supplied the implants notifying the potential defendants of the claim and that the women are seeking recovery of the cost of removal of the implants and compensation for personal injury, distress and any consequent financial loss.
It will be the first legal action in the UK by women who have BIA-ALCL and those who claim they were not properly warned about the risks from the implants. The Allergan Biocell textured implants have been linked to a rare form of cancer called anaplastic large cell lymphoma, BIA-ALCL.
The London and Manchester law firm said it has received enquires from over 350 women who have the implants. Eleven of the women it represents have developed.
USA
Aug 2019, Class Action Lawsuit, against Allergan has been announced by Berger Montague PC, Sauder Schelkopf, And Mazie Slater Katz & Freeman, To Protect Women From The Increased Risk Of Cancer Resulting From Textured Breast Implants And For Economic Damages Aug. 19, 2019 /PRNewswire/ — The law firms of Berger Montague PC, Sauder Schelkopf, and Mazie Slater Katz & Freeman announce that a nationwide class action lawsuit has been filed against the medical device manufacturer Allergan to protect women with Allergan’s textured breast implants from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which has now been associated with Allergan’s BIOCELL textured breast implants. The case is Jane Doe I, et al. v. Allergan, Inc., et al., No. 2:19-cv-16784 (D.N.J.)
CANADA
May 23, 2019, Thomson Rogers and Rochon Genova LLP issued a class action on behalf of Canadians who were implanted with breast implants manufactured and distributed by Allergan plc and several of its affiliates.
Merchant Law Group LLP has launched Canada-wide class action litigation against Allergan, the manufacturer of Biocell textured breast implants, seeking financial compensation on behalf of all Canadian women who have been diagnosed with anaplastic large cell lymphoma (BIA-ALCL) which is a serious but rare type of non-Hodgkin lymphoma that affects the immune system (and may develop many months or years after a breast implant procedure) as a result of receiving Biocell textured breast implants.
AUSTRALIA
“The Australian Society of Plastic Surgeons would support the TGA should it decide to ban Allergan textured implants,” he said.
He said they would also support the banning of a second newer type of implant made from polyurethane, which has also been linked to the lymphoma.
Under the proposal, nine different products made by Allergan, including Natrelle Truform, Soft touch and Inspira, are facing cancellation that would include the recall of all remaining products on the market.
Other products including Adirel Nagor, Emagin, Emergo, Euro Implants, JT medical, and Johnson & Johnson’s siltex products are facing suspensions, which can be revoked if concerns about the products are addressed. If the suspension goes ahead, those products will be recalled from hospital shelves.
“No decision has been made to suspend or cancel the relevant products at this time,” the TGA said in a statement.
“The TGA is required by law to provide the sponsors of affected implants with an opportunity to make submissions in response to proposed regulatory action.
“The TGA will then take into consideration each sponsor’s submission when deciding what, if any, regulatory action should be taken in relation to a particular sponsor’s device.”
Breast implant makers and distributors have until July 24 to respond before the regulator makes a final decision.
It comes after the TGA did its own lab testing and statistical analysis.
The TGA has also imposed a condition on Allergan, Emagin and JT medical that they must provide patients getting certain products with an information leaflet outlining risks and benefits.
Grade three and four implants previously removed from the market for other reasons, but which still carry the increased risk, include Silimed polyurethane implants and Surgitek implants.
The regulator said women with affected implants did not need to have them removed but did need to be aware of potential symptoms and see their doctor if they were concerned. In a statement, Allergan said it continued to stand behind the benefit-risk profile of its breast implants, including it Biocell products.
“The company is actively reviewing the TGA’s proposed regulatory action on Natrelle Biocell textured breast implants and tissue expanders, as well as its invitation to submit a response to the proposed action as a matter of priority”
FRANCE
April 2019, France decided to ban all breast implants that are macro-textured and have polyurethane coating due to an increased risk of a rare form of lymph node cancer. The Minister asked public health institute RIVM to assess the French documents on this topic. The RIVM concluded that there is insufficient evidence for a general relationship between rough-surface implants and an increased risk of that cancer. There is one specific implant – Biocell implants by Allergan – for which this link is plausible, but that implant has already been removed from the market.
THE NETHERLANDS
The Netherlands will not ban breast implants with a rough surface amid concerns that they may increase the risk of a rare form of lymph node cancer. But the Dutch government will tighten the rules for the use of implants in breast reconstruction and breast enlargements in an effort to make sure that all women who have them are as safe as possible, Minister Bruno Bruins for Medical Care said in a letter to parliament. The Netherlands’ association for plastic surgery NVPC is currently working on new guidelines on breast prosthesis surgery. This will require doctors to inform patients about all risks involved with implants and about alternative treatments. Both doctor and patient will have to sign a declaration that this was explained to them and they understand. The new guidelines will also include periodic follow-up care for all people with breast implants, so that any possible problems can be identified early. The new guideline is expected to be ready by the end of this year. In the meantime, the NVPC will actively approach the over 60 thousand women in the Netherlands with Allergan-Biocell implants so that they can be examined.
KOREA
Koreans who received breast implants using Allergan’s specific product are to pursue a class-action lawsuit,Lincoln Law Firm is leading the suit. The law firm plans to gather people to join the lawsuit until Aug. 31 and file the first suit against Allergan, not Allergan Korea, for damage compensation in September.
The participants will be those who had Allergan’s BIOCELL textured implants.
GENERAL
You may have a breast implant cancer lawsuit if you underwent a breast augmentation surgery cosmetically or reconstructively and have been diagnosed with ALCL. ALCL can be diagnosed years later as most cases have been found years after the initial surgery took place. BIA-ALCL lawsuit claims can be for one or more of the following:
- Defective design and/or manufacturing
- Failure to warn
- Negligence
- Punitive damage
- Attorney fees
- Compensation for these claims can involve medical expenses, lost wages, and pain and suffering.
For information about revision surgery and alternatives to implants go to More Information
